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1. 3 6 Damaged Test Kits In case of any damage to the test kit or components DRG must be informed in writing at the latest one week after receiving the kit Damaged single components should not be used for a test run They have to be stored until a final solution has been found After this they should be disposed of according to the official regulations 4 SPECIMEN COLLECTION AND PREPARATION Serum or plasma EDTA heparin or citrate plasma can be used in this assay A minimum of 85 uL of sample is needed for one determination This includes 25 uL sample and 60 uL dead volume Attention This test was not verified with blood collection tubes of all available manufacturers Sample Collection Systems of some manufacturers may contain different materials which in isolated cases could affect the test results If primary tubes for sample collection are used please follow the instructions of the manufacturer Do not use haemolytic icteric or lipaemic specimens Samples containing precipitates have to be centrifuged prior to the test run Do not use heat inactivated samples Do not use standards or external controls stabilized with azide 4 1 Specimen Collection Serum Collect blood by venipuncture e g Sarstedt Monovette for serum allow to clot and separate serum by centrifugation at room temperature Do not centrifuge before complete clotting has occurred Presence of anticoagulant may require increased clott
2. DIRE CG DRG HYBRiDeXL Estradiol HYE 5349 USA As of 27 Nov 2013 rm Vers 2 1 THIS KIT IS INTENDED FOR RESEARCH USE ONLY NOT INTENDED FOR USE IN DIAGNOSTIC PROCEDURES Intended Use The DRG HYBRiD XL Estradiol is an enzyme immunoassay for measurement of estradiol in serum and plasma Only for use with the DRG HYBRID XL Analyzer 1 PRINCIPLE OF THE TEST The DRG HYBRiD XL Estradiol Kit is a solid phase enzyme linked immunosorbent assay ELISA based on the principle of competitive binding The antibody coated wells ACW of the reagent cartridges are coated with a polyclonal antibody directed towards a unique antigenic site of the estradiol molecule Endogenous estradiol of a sample competes with an estradiol horseradish peroxidase conjugate for binding to the coated antibody After incubation the unbound conjugate is washed off The amount of bound peroxidase conjugate is inversely proportional to the concentration of estradiol in the sample Having added the substrate solution the intensity of colour developed is inversely proportional to the concentration of estradiol in the sample 2 WARNINGS AND PRECAUTIONS 1 For professional use only 2 This kit can only be used in combination with the DRG HYBR1D XL Analyzer 3 Before starting the assay read the instructions completely and carefully Use the valid version of the package insert provided with the kit Be sure that everything is clear and understood 4 Do not
3. 17 hydroxyprogesterone and estradiol 178 during the menstrual cycle J Clin Endocrinol Metab 34 312 18 1972 March C M Goebelsmann U Nakumara R M and Mishell D R Roles of oestradiol and progesterone in eliciting midcycle luteinising hormone and follicle stimulating hormone surges J Clin Endicrinol Metab 49 507 12 1979 Simpson E R and McDonald P C Endocrinology of Pregnancy In Textbook of Endocrinology Ed Williams R H pp412 22 Saunders Company Philadelphia 1981 Jenner M R Kelch R P et al Hormonal Changes in prepubertal children pubertal females and in precocious puberty premature thelarche hypogonadism and in a child with feminising tumour J Clin Endocrinol 34 521 1982 Goldstein D et al Correlation between oestradiol and progesterone in cycles with luteal phase deficiency Fertil Steril 37 348 54 1982 DRG International Inc USA Fax 973 564 7556 e mail corp drg international com 7 DIRE 6 DRG HYBRiDeXL Estradiol HYE 5349 USA As of 27 Nov 2013 rm Vers 2 1 13 14 15 16 17 18 19 20 2M Kirschner M A therole of hormones in the etiology of human breast cancer Cancer 39 2716 26 1977 Odell W D and Swerdloff R D Abnormalities of gonadal function in men Clin Endocr 8 149 80 1978 McDonald P c Madden J C Brenner P F Wilson J D and Siiteri P K Origin of oestrogen in normal men and women with testicular
4. allowed to come to room temperature 20 C to 25 C before use All reagents and samples must be mixed without foaming Reagent Cartridges can be used directly after storage in the refrigerator Once the test has been started all steps should be completed without interruption Samples controls and re calibrators should be measured within 2 hours in order to avoid possible evaporation effects The Secondary Sample Holder HY1 5437 for secondary tubes has the capacity for a maximum of 20 samples including controls and re calibrators They all have to be pipetted into the secondary tubes and the respective barcodes of control re calibrator vials and if available the sample barcodes have to be read with the external barcode scanner 5 2 Test Procedure To ensure proper operation of the test the instructions in the user manual for the DRG HYBRiD XL should strictly be followed All test specific information required for the correct operation 1s included in the respective barcodes of the reagents Take care not to damage these bar codes It is recommended to tap the bottom of the Cartridge Segments containing the reagent cartridges once on the bench before placing them on the rotor This is to avoid foam and adhering of the liquid on the sealing of the reagent cartridge Place reagent cartridges on the rotor of the unit The heating to 37 C incubation temperature is performed automatically in the unit 5 3 Ca
5. remove exchange discard or damage any of the barcode labels provided with each kit and its components All barcodes build an integral system for the kit lot 5 Respect the general safety measures for use of laboratory reagents 6 All reagents of this test kit which contain human serum or plasma have been tested and confirmed negative for HIV I II HBsAg and HCV by FDA approved procedures All reagents however should be treated as potential biohazards in use and for disposal 7 Never pipet by mouth and avoid contact of reagents and specimens with skin and mucous membranes 8 Do not smoke eat drink or apply cosmetics in areas where specimens or kit reagents are handled 9 Wear appropriate disposable gloves when handling specimens and reagents Microbial contamination of reagents or specimens may cause false results 10 Handling should be done in accordance with the procedures defined by an appropriate national biohazard safety guideline or regulation 11 Do not use reagents beyond expiry date as shown on the kit labels 12 Unused reagent cartridges must be stored at 2 C to 8 C in the sealed foil pouch with desiccant provided 13 Optimal test results are only obtained when using calibrated pipettes 14 Do not mix or use components from kits with different lot numbers It is advised not to interchange reagent cartridges of different kits even of the same lot The kits may have been shipped or stored under different conditions and t
6. ES Tsang B K Armstrong D T and Whitfield J F Steroid biosyntheses by isolated human ovarian follicular cells in vitro J Clin Endocrinol Metab 51 1407 11 1980 Gore Langton R E and Armstrong D T Follicular steroidogenesis and its control In The physiology of Reproduction Ed Knobil E and Neill J et al pp 331 85 Raven Press New York 1988 Hall P F Testicular Steroid Synthesis Organization and Regulation In The Physiology of Reproduction Ed Knobil E and Neill J et al pp 975 98 Raven Press New York 1988 Suter1 P K Murai J T Hammond G L Nisker J A Raymoure W J and Kuhn R W The serum transport of steroid hormones Rec Prog Horm Res 38 457 510 1982 Martin B Rotten D Jolivet A and Gautray J P Binding of steroids by proteins in follicular fluid of the human ovary J Clin Endocrinol Metab 35 443 47 1981 Baird D T Ovarian steroid secretion and metabolism in women In The Endocrine Function of the Human Ovary Eds James V H T Serio M and Giusti G pp 125 33 Academic Press New York 1976 McNastty K P Baird D T Bolton a Chambers P Corker C S and McLean H concentration of oestrogens and androgens in human ovarian venous plasma and follicular fluid throughout the menstrual cycle J Endocrinol 71 77 85 1976 Abraham G E Odell W D Swerdloff R S and Hopper K Simultaneous radioimmunoassay of plasma FSH LH progesterone
7. atory Practice or other applicable national standards and or laws This is especially relevant for the use of control reagents It 1s important to always include within the test procedure a sufficient number of controls for validating the accuracy and precision of the test The test results are valid only if all controls are within the specified ranges and if all other test parameters are also within the given assay specifications In case of any doubt or concern please contact DRG DRG International Inc USA Fax 973 564 7556 e mail corp drg international com 6 DIRE Co DRG HYBRiDeXL Estradiol HYE 5349 USA As of 27 Nov 2013 rm Vers 2 1 8 2 Liability Any modification of the test kit and or exchange or mixture of any components of different kit lots could negatively affect the intended results and validity of the overall test Such modification and or exchanges invalidate any claim for replacement Claims submitted due to customer misinterpretation of laboratory results are invalid Regardless in the event of any claim the manufacturer s liability is not to exceed the value of the test kit Any damage caused to the test kit during transportation is not subject to the liability of the manufacturer For further information please refer to the User Manual of the DRG HYBRiD XL analyser specific application sheets product information and package inserts of all necessary components 10 11 1 REFERENC
8. feminisation J Clin Endcrinol Metabol 49 905 1979 Peckham M J and McElwain T J Testicular tumours J Clin Endocrinol Metab 4 665 692 1975 Taubert H d and Dericks Tan J s E Induction of ovulation by clomiphene citrate in combination with high doses of oestrogens or nasal application of LH RH In Ovulation in the Human Eds Crosignandi P G and Mishell D R pp 265 73 Academic Press New York 1976 Fishel S B Edwards R G Purdy J M Steptoe P C Webster J Walters E cohen J Fehilly C Hewitt J and Rowland G Implantation abortion and birth after in vitro fertilisation using the natural menstrual cycle or follicular stimulation with clomiphene citrate and human menopausal gonadotropin J In Vitro Fertil Embryo Transfer 1 24 28 1985 Wramsby H Sundstorm P and Leidholm P Pregnancy rate in relation to number of cleaved eggs replaced after in vitro fertilisation of stimulating cycles monitored by serum levels of oestradiol and progesterone as sole index Human Reproduction 2 325 28 1987 Ratcliff W A Carter G D et al Estradiol assays applications and guidelines for the provision of clinical biochemistry service Ann Clin Biochem 25 466 483 1988 Tietz N W Textbook of Clinical Chemistry Saunders 1986 11 12 13cc DRG International Inc USA Fax 973 564 7556 e mail corp drg international com 8
9. he binding characteristics of the wells in the reagent cartridges may differ slightly DRG International Inc USA Fax 973 564 7556 e mail corp drg international com 1 DIRE 6 DRG HYBRiDeXL Estradiol HYE 5349 C E USA As of 27 Nov 2013 rm Vers 2 1 15 Some reagents contain Proclin 300 BND and or MIT as preservatives In case of contact with eyes or skin flush immediately with water 16 TMB substrate has an irritant effect on skin and mucosa In case of possible contact wash eyes with an abundant amount of water and skin with soap and plenty of water Wash contaminated objects before reusing them If inhaled take the person to open air 17 Chemicals and prepared or used reagents have to be treated as hazardous waste according to the national biohazard safety guidelines or regulations 18 For information on hazardous substances included in the kit please refer to Safety Data Sheets For professional users the Safety Data Sheet for this product is available upon request directly from DRG 3 REAGENTS 3 1 Reagents provided 3 1 1 Reagent Cartridges 40 pieces containing the following Antibody Coated Well ACW coated with anti estradiol antibody polyclonal Enzyme Conjugate 260 uL estradiol antigen conjugated with horseradish peroxidase Contains non mercury preservative Substrate Solution 260 uL Tetramethylbenzidine TMB 3 1 2 Re Calibrator 1 amp 2 2 vials 1 mL each read
10. ily and weekly maintenance see also user manual HYI 5387 Cuvettes 2 x 360 pieces For use of the Secondary Sample Holder for secondary tubes the following tubes are required HYI 5391 Sample Tubes Secondary 2500 pcs 3 3 Storage Conditions When stored at 2 C to 8 C unopened reagents will retain reactivity until expiration date Do not use reagents beyond this date Opened reagents and the reagent cartridges must be stored at 2 C to 8 C Once the foil bag has been opened care should be taken to tightly close it again Opened kits retain activity for three months if stored as described above 3 4 Reagent Preparation Bring all reagents such as controls and re calibrators to room temperature 20 C to 25 C prior to use Reagent Cartridges can be used directly after storage in the refrigerator Wash Buffer not included in the kit For Wash Buffer 1x dilute 25 mL of Wash Buffer 40x with 975 mL ultra pure water to a final volume of 1000 mL The diluted Wash Buffer 1x is stable for 2 weeks at room temperature DRG International Inc USA Fax 973 564 7556 e mail corp drg international com 3 DIRE Ls DRG HYBRiDeXL Estradiol HYE 5349 USA As of 27 Nov 2013 rm Vers 2 1 3 5 Disposal of the Kit The disposal of the kit and all used materials reagents must be performed according to the national regulations Special information for this product is given in the Safety Data Sheet
11. ing time Plasma Whole blood should be collected into centrifuge tubes containing anti coagulant e g Sarstedt Monovette with the appropriate plasma preparation and centrifuged immediately after collection 4 2 Specimen Storage and Preparation Specimens should be capped and may be stored for up to 7 days at 2 C to 8 C prior to performing the assay Specimens stored for a longer time up to one year should be frozen at 20 C prior to the assay 3 freeze thaw cycles are possible Thawed samples should be inverted several times prior to testing 4 3 Specimen Dilution 4 3 1 Manual Sample Dilution If in an initial assay a specimen is found to contain more than the highest standard the specimens can be diluted with Sample Diluent and reassayed as described in Assay Procedure For the calculation of the concentrations this dilution factor has to be taken into account DRG International Inc USA Fax 973 564 7556 e mail corp drg international com 4 DIRE CG DRG HYBRiDeXL Estradiol HYE 5349 USA As of 27 Nov 2013 rm Vers 2 1 Example a dilution 1 10 10 uL sample 90 uL Sample Diluent mix thoroughly b dilution 1 100 10 uL dilution a 1 10 90 uL Sample Diluent mix thoroughly Sample Diluent for manual dilution is not included in this kit but can be ordered on request 5 ASSAY PROCEDURE 5 1 General Remarks All reagents such as controls and re calibrators and specimens must be
12. libration Traceability This method was standardized against the DRG Estradiol ELISA EIA 2693 Each DRG HYBR1D XL reagent contains a barcode with the specific information for recalibration of the reagent lot The Master Curve is printed as a 2 D barcode on the outer label of the kit package and on the QC Datasheet and has to be scanned with the external barcode scanner prior to the first use of the respective kit lot Recalibration is recommended if one or both assay controls are found outside the specified range after 4 weeks of use of the same reagent kit on the unit 5 4 Calculation of Results The analyte concentrations are calculated automatically by the DRG HYBRiD XL s system software DRG International Inc USA Fax 973 564 7556 e mail corp drg international com 5 DIRE 6 DRG HYBRiDeXL Estradiol HYE 5349 USA As of 27 Nov 2013 rm Vers 2 1 6 QUALITY CONTROL It is recommended to use control samples according to state and federal regulations The use of control samples is advised to assure the day to day validity of results Apply appropriate statistical methods for analysing control values and trends Please check the following expiration dates and storage conditions of reagents operational reliability of the analyser In addition it is indicated to perform a Recalibration In case of further questions please contact your local distributor or DRG directly 6 1 Internal Controls For Q
13. uality Control it is necessary to use the two internal controls provided with each kit Acceptance ranges for both internal controls Control 1 amp 2 were established by the manufacturer and are summarized in the QC Datasheet added to the kit Note that the expected values and acceptance ranges stated in the QC Datasheet always refer to the current kit lot Internal controls should be run in single determination on a routine basis e g once per 24 h if re calibration is required if one or both internal controls are out of range if a new kit lot is used in order to avoid any negative impact on the kit performance by improper transport or to detect improper storage during transport 6 2 External Controls Use controls at both normal and pathological levels The control intervals and control ranges for external controls should be adapted to the individual requirements of each laboratory All results must be within the defined limits Each laboratory should establish corrective measures to be taken if values of external controls are not found in the acceptance range 7 LIMITATIONS OF USE Adhere to good laboratory practice Any improper handling of samples or modification of this test might influence the results 8 LEGAL ASPECTS 8 1 Reliability of Results The test must be performed exactly as per the manufacturer s instructions for use Moreover the user must strictly adhere to the rules of GLP Good Labor
14. y to use For re calibration of the quantitative DRG HYBRi1D XL Estradiol test Concentrations are lot specific Conversion 1 pg mL 3 67 pmol L Contain non mercury preservative 3 1 3 Control 1 amp 2 2 vials 1 mL each ready to use For control values and ranges please refer to the bar code on vial label or to the QC Datasheet Contain non mercury preservative DRG International Inc USA Fax 973 564 7556 e mail corp drg international com 2 DIRE CG DRG HYBRiDeXL Estradiol HYE 5349 USA As of 27 Nov 2013 rm Vers 2 1 3 2 Materials required but not provided General needed laboratory equipment Ultra pure water DRG recommends to use Clinical Laboratory Reagent Water CLRW according to CLSI guideline 3C A4 with the following specifications Resistivity at 25 C MQ cm gt 10 Conductivity at 25 C uS cm lt 0 1 Total Organic Carbon p p b ug L lt 50 Colloids g mL lt 0 05 REF HYB 5252 DRG HYBRiD XL Analyzer IREF HYI 5392 System Solution 5L 5000 mL Instrument Feed Water according to CLSI guideline 3C A4 with the following specification can also be used Resistivity at 25 C MQ cm gt 1 Conductivity at 25 C uS cm 1 lt 1 Total Organic Carbon p p b ug L lt 200 Colloids ug mL lt 0 1 IREF HYI 5394 Wash Buffer 40x concentrate 25 mL REF HYI 5395 Needle Cleaning Solution 30 mL Cleaning solution for the pipetting needle da

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